Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
publication
Title:
Dicyanodiamide
Author:
DFG, Deutsche Forschungsgemeinschaft
Year:
2007
Bibliographic source:
The MAK-Collection PartI: MAK Value Documentations, Vol. 24

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Not specified in the assessment.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: 3% gum arabic solution
Details on oral exposure:
In the diet in concentrations of 0, 12500, 25000, 50000 and 100000 mg/kg diet corresponding to about 0, 570, 1250, 2600 and 5800 mg/kg body weight per day for males and 0, 700, 1500, 3000 and 6800 mg/kg body weight per day for females based on body weight
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
Daily
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
At 12500 mg/kg diet and above.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
At 12500 mg/kg diet and above.
Food efficiency:
effects observed, treatment-related
Description (incidence and severity):
At 12500 mg/kg diet and above.
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
At 12500 mg/kg diet and above.
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
At 12500 mg/kg diet and above.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
At 12500 mg/kg diet and above.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
570 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs

Target system / organ toxicity

Key result
Critical effects observed:
yes
Lowest effective dose / conc.:
570 mg/kg bw/day (nominal)
System:
haematopoietic
Organ:
blood
Treatment related:
yes
Dose response relationship:
yes
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL for the test substance in a 90-day feeding study in rats was 570 mg/kg bw/day.